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This is VAERS ID 335641

Case Details

VAERS ID: 335641 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Female  
Location: Foreign  
Vaccinated:2008-09-02
Onset:2008-11-11
   Days after vaccination:70
Submitted: 2008-12-18
   Days after onset:37
Entered: 2008-12-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal distension, Abdominal pain, Abdominal wound dehiscence, Appendicectomy, Gastrointestinal sounds abnormal, Haematochezia, Intestinal anastomosis, Intestinal obstruction, Intussusception, Ischaemia, Mucous stools, Pallor, Rectal haemorrhage, Surgery, Ultrasound abdomen abnormal, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Hypotonic-hyporesponsive episode (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 22 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Ultrasound abdomen, 12Nov2008, abnormal
CDC Split Type: B0549773A

Write-up: This case was reported by a physician in the frame of a PASS study and described the occurrence of ileocolic intussusception in a 6-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject was under no other medication and had no relevant medical history nor allergy. Previous and/or concurrent vaccination included diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis and Haemophilus influenzae type b vaccine; manufacturer unspecified; intramuscular; given on 5 November 2008; hepatitis B vaccine recombinant; manufacturer unspecified; intramuscular; given on 5 November 2008; influenza virus vaccine; manufacturer unspecified; intramuscular; given on 5 November 2008; live attenuated human rotavirus vaccine; GlaxoSmithKline; oral given on 2 July 2008. On 2 September 2008, the subject received 2nd dose of ROTARIX (oral), lot number not provided). On 11 November 2008, 70 days after vaccination with ROTARIX, the subject experienced rectal bleeding with mucus and gastroalimentary vomiting. On 12 November 2008, the subject was hospitalised. At admission, physical examination revealed pallor, abdominal distension with pain to the deep palpation, bowel sounds decreased and currant jelly stool. The abdominal ultrasound showed an intestinal obstruction and intussusception. Surgery was performed and ileocolic intussusception with appendicular ischemia was found and reduced by taxis. An appendectomy was also performed with a bad evolution. A second intestinal obstruction with multiple end to end anastomosis and dehiscent appendicular stump was diagnosed, leading to 2nd surgery on 19 November 2008. The events were resolved by anastomosis destruction, lysis and reconstruction of appendicular stump. The events were resolved by anastomosis destruction, lysis and reconstruction of appendicular stump. Intestinal resection was not performed. The subject was hospitalized for 22 days. The subject was treated with RANITIDINE, AMPICILLIN, amikacin and METAMIZOLE. On 3 December 2008, the events were resolved and the subject was discharged from hospital in good clinical condition. The physician considered the events were unrelated to vaccination with ROTARIX.


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